The present invention relates, in general, to medical devices containing an integrated lancet and sensor and, more particularly, to a process for packaging the medical devices including integrated lancets.
The determination of analyte concentration in physiological samples is of ever increasing importance to today's society. Such assays find use in a variety of application settings, including clinical laboratory testing, home testing, etc., where the results of such testing play a prominent role in the diagnosis and management of a variety of disease conditions. Analytes of interest include glucose for diabetes management, cholesterol for monitoring cardiovascular conditions, drugs for monitoring levels of therapeutic agents, and identifying illegal levels of drugs, and the like. In response to this growing importance of analyte characteristic (e.g., concentration) determination, a variety of analyte characteristic determination protocols and devices for both clinical and home testing have been developed.
In determining the concentration of an analyte in a physiological sample, a physiological sample must first be obtained. Obtaining and testing the sample often involves cumbersome and complicated procedures. Unfortunately, successful manipulation and handling of test elements, such as test strips, lancing members, meters and the like is to a great extent dependent on the visual acuity and manual dexterity of the user, which in the case of people with diabetes is subject to deterioration over the course of the disease state. In extreme cases people that have significant loss of sight and sensation, testing procedures can become significantly difficult and requires additional assistance from ancillary devices or personnel.
A typical procedure for making a glucose measurement with the use of a test strip involves multiple actions or steps. One manner of reducing the number of actions is by the use of integrated medical devices that combine multiple functions in order to minimize the handling of sensor and/or lancing components that may lead to contamination of the components and/or injury to the user. An example of such an integrated medical device that includes a test strip and lancet is described in International Application No. PCT/GB01/05634 (published as WO 02/49507 on Jun. 27, 2002; and U.S. patent application Ser. No. 10/143,399; published as 2003/0143113 A2 on Jul. 31, 2003), both of which are fully incorporated herein by reference.
Technological advancements have been made in test strip fabrication in which both sensor and lancing functions and the structures to provide such functions are provided on a single fully integrated medical device, as described in the aforementioned U.S. patent application Ser. No. 10/143,399. Integrated medical devices are typically in the form of strips. Web-based methods can be used to make such fully integrated medical devices which are singulated after fabrication prior to being collectively packaged in a cartridge, magazine, cassette or the like. Examples of web-based methods for making such medical devices are disclosed in U.S. patent application Ser. No. 10/142,409 published as 2003/0211619 A1 on Nov. 13, 2003) and European Patent Application EP 1360932 A1, both of which are fully incorporated herein by reference.
Integrated medical devices can be singly or collectively loaded into a storage container (s) or package(s) manually. However, this is difficult due to the small size of the devices, is time consuming, can possibly damage the lancing portion (e.g., micro-needle) as the device is inserted into the container, and can result in improper alignment of the device within the container. Examples of containers for integrated medical devices are described in co-pending U.S. patent application Ser. No. 10/666,154, which is fully incorporated herein by reference.
Still needed in the field, therefore, is an automated method of loading an integrated medical device into a container without damaging the micro-needle while ensuring that the device is at the proper orientation for subsequent extraction by a user.